Home NDC 62756-529 desmopressin acetate
Product NDC 62756-529
11-digit product format 627560529
Labeler code 62756
Product ID 62756-529_129770b0-b59a-4ee3-bc07-2168544c1424
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name desmopressin acetate
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS; SUBCUTANEOUS
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA091280
Marketing category ANDA
Marketing start 2014-02-20
Substance DESMOPRESSIN ACETATE
Active strength 4 ug/mL
Pharmacologic classes Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 62756-529 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 62756-529 62756-529-26 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091280-001 DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION 2013-01-25
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A091280-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION 2013-01-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091280-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION 2013-01-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091280-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION 2013-01-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091280-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION 2013-01-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091280-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION 2013-01-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091280-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION 2013-01-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091280-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION 2013-01-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091280-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION 2013-01-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091280-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2013-01-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091280-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION 2013-01-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091280-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2013-01-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091280-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2013-01-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091280-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2013-01-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091280-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2013-01-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091280-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2013-01-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091280-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2013-01-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091280-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2013-01-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091280-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2013-01-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091280-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2013-01-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091280-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2013-01-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091280-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2013-01-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091280-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2013-01-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091280-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2013-01-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091280-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2013-01-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091280-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2013-01-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091280-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2013-01-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091280-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2013-01-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091280-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2013-01-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091280-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2013-01-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091280-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2013-01-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091280-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2013-01-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091280-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2013-01-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091280-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2013-01-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091280-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2013-01-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091280-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2013-01-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091280-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2013-01-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091280-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2013-01-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091280-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2013-01-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091280-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2013-01-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091280-001 DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP 2013-01-25 e64feba35796…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base desmopressin acetate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DESMOPRESSIN ACETATE 4 ug/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination XB13HYU18U Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 849501 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 62756-529-40 Desmopressin Acetate 1 in 1 CARTON INJECTION, SOLUTION 1 6 62756-529-40 Desmopressin Acetate 10 mL in 1 VIAL INJECTION, SOLUTION 10 6 62756-529-26 desmopressin acetate 1 in 1 CARTON INJECTION, SOLUTION 1 3 62756-529-26 desmopressin acetate 10 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 10 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DESMOPRESSIN ACETATE ACTIVE INGREDIENT XB13HYU18U DESMOPRESSIN ACETATE (DESMOPRESSIN ACETATE ) INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 3 DESMOPRESSIN ACTIVE MOIETY ENR1LLB0FP DESMOPRESSIN ACETATE (DESMOPRESSIN ACETATE ) INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 3 CHLOROBUTANOL HEMIHYDRATE INACTIVE INGREDIENT 3X4P6271OX DESMOPRESSIN ACETATE (DESMOPRESSIN ACETATE ) INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 3 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB DESMOPRESSIN ACETATE (DESMOPRESSIN ACETATE ) INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 3 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X DESMOPRESSIN ACETATE (DESMOPRESSIN ACETATE ) INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 3 WATER INACTIVE INGREDIENT 059QF0KO0R DESMOPRESSIN ACETATE (DESMOPRESSIN ACETATE ) INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 3 DESMOPRESSIN ACETATE ACTIVE INGREDIENT XB13HYU18U DESMOPRESSIN ACETATE INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 2 DESMOPRESSIN ACTIVE MOIETY ENR1LLB0FP DESMOPRESSIN ACETATE INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 2 CHLOROBUTANOL HEMIHYDRATE INACTIVE INGREDIENT 3X4P6271OX DESMOPRESSIN ACETATE INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 2 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB DESMOPRESSIN ACETATE INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 2 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X DESMOPRESSIN ACETATE INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 2 WATER INACTIVE INGREDIENT 059QF0KO0R DESMOPRESSIN ACETATE INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62756-529 DESMOPRESSIN ACETATE (DESMOPRESSIN ACETATE ) INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.] 6 Current NDC, Legacy NDC, 2 package rows 20220827_9fd48eec-aa24-4888-b99f-d409ada958a7.zip 62756-529 DESMOPRESSIN ACETATE INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.] 3 Current NDC, Legacy NDC, 2 package rows 20200124_2dc2cec8-6953-4a33-9356-11534fba1fb8.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 62756-529-26 62756052926 1 VIAL, MULTI-DOSE in 1 CARTON (62756-529-26) / 10 mL in 1 VIAL, MULTI-DOSE 2014-02-20 0000-00-00 No No Current 62756-529-40 62756052940 1 VIAL in 1 CARTON (62756-529-40) / 10 mL in 1 VIAL 1 vial 2013-01-30 0000-00-00 No No Current